Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-122-6 | CAS number: 5285-60-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Biodegradation in soil
Administrative data
- Endpoint:
- biodegradation in soil: simulation testing
- Type of information:
- experimental study planned
- Study period:
- As soon as testing proposal is agreed upon by ECHA
- Justification for type of information:
- TESTING PROPOSAL FOR OECD 307 WITH 4,4’-methylenebis-N-sec-butylaniline (MDBA)
In order to come to an unequivocal conclusion on the PBT properties of the substance, further information is needed. MDBA has a partitioning coefficient (Log Kow) of 5.4. In order to determine the Bioaccumulative properties of the substance, a bioconcentration study was conducted. Based on the results collected in the present study, the test item is considered to be bioaccumulative in fish at a nominal exposure concentration of 0.6 μg/L and very bioaccumulative at a nominal exposure concentration of 6 μg/L when considering total radioactive residue concentrations. When considering parent related radioactive residue concentrations, uptake in fish tissue was still significant but formed on average about 40-50% of the total radioactive residue concentrations. Therefore it can be concluded that the substance MDBA is very Bioaccumulative (vB). The substance is T, since the substance is classified as STOT RE category 2 based on an OECD 422 study.
The ready biodegradation study revealed that the substance is not readily biodegradable and therefore potentially P or vP. Further testing is necessary to come to an unequivocal conclusion on the persistence properties of the substance.
SELECTION OF THE RELEVANT ENVIRONMENTAL COMPARTMENT:
1.Testing in the sediment and/or soil compartments should be considered in particular if there is a specific concern for this compartment, for example, if direct or indirect releases to these compartments are likely, or if the substance is predicted to accumulate in these compartments. Koc or Kd values can be used as an indicator of whether the substance is likely to be of concern for the sediment and soil compartments. As a rule of thumb, substances with log Koc > 4 are generally regarded as highly adsorptive and likely to distribute in sediment and soil. Since the log Koc of 4,4’-methylenebis-N-sec-butylaniline (MDBA) is 5.19, there is a specific concern for the soil and sediment compartment.
2. Since MDBA is likely to break down into the ‘backbone’ structure of the starting material, it can be assumed that based on this information, this substance will have similar persistence properties as the starting material 4,4’-methylenedianiline (EC 202-974-4) and therefore information from 4,4’-methylenedianiline can be used as a starting point for 4,4’-methylenebis-N-sec-butylaniline (MDBA).
According to the disseminated dossier of the starting material 4,4’-methylenedianiline (EC 202-974-4), this substance is considered Persistent in the environment (P, not vP): “Although simulation tests in water and sediment indicate that the substance is not persistent in these environmental media, data from soil degradation tests under aerobic and anaerobic conditions lead to the assumption, that the substance might be persistent (P) but not very persistent (not vP) in soil. At the beginning of the test biodegradation occurs while at a later stage no biodegradation occurs. This is likely due to binding to organic soil matter e. g. humic acids. Hence, the substance is not bioavailable for degradation anymore."
Since the simulation tests in water and sediment indicate that the starting material 4,4’-methylenedianiline (EC 202-974-4) is not persistent in these environmental media and in soil it might be persistent, further investigation of the persistence properties of 4,4’-methylenebis-N-sec-butylaniline (MDBA) by performing the OECD 307 study is considered as the most likely route to an unequivocal outcome of the PBT assessment.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 4,4'-methylenebis-N-sec-butylaniline (MDBA)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: none available for the registered substance
- Available non-GLP studies: none available for the registered substance
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The substance is not readily biodegradable
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 307 (Aerobic and Anaerobic Transformation in Soil)
- Test type:
- laboratory
Test material
- Reference substance name:
- 4,4'-methylenebis[N-sec-butylaniline]
- EC Number:
- 226-122-6
- EC Name:
- 4,4'-methylenebis[N-sec-butylaniline]
- Cas Number:
- 5285-60-9
- Molecular formula:
- C21H30N2
- IUPAC Name:
- 4,4'-methylenebis[N-sec-butylaniline]
Constituent 1
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.